COVIDISC: Rapid Diagnostic Tests on Nasopharyngeal Swabs for the Detection of COVID-19 (COVIDISC)
Primary Purpose
COVID-19, SARS-CoV-2
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rapid Diagnostic Test vs PCR
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing nasopharyngeal SARS CoV2 RT-PCR testing
Exclusion Criteria:
- < 18 years old
- Having signed a written informed consent form,
- Affiliation to the social security system.
Sites / Locations
- CHI Robert Ballanger
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nasopharyngeal swabs
Arm Description
One patient will have 2 nasopharyngeal for PCR and COVIDISC
Outcomes
Primary Outcome Measures
Comparaison of the performance of the diagnostic performance (sensitivity, sensibility) of RT-LAMP test using the RT-PCR test as a reference.
Calculate sensitivity, Specificity, Positive predictive value, Negative predictive value, Positive and negative likelihood report COVIDISC fast, antigenic test compared to RT-PCR Covid-19 reference test conducted in the laboratory
Secondary Outcome Measures
Compare the diagnostic performances of RT-LAMP to clinical diagnosis.
The result of RT-LAMP test versus clinical evaluation defined by the clinical symptoms of the patients at the time of nasopharyngeal swab.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04703140
Brief Title
COVIDISC: Rapid Diagnostic Tests on Nasopharyngeal Swabs for the Detection of COVID-19
Acronym
COVIDISC
Official Title
Evaluation of the Performance of COVIDISC Rapid Test for Diagnosis of SARS-CoV-2
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Non-significant intemedial analysis
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
May 4, 2021 (Actual)
Study Completion Date
May 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CMC Ambroise Paré
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Covid-19 pandemic requires a reliable diagnosis of patients in order to take care of them in the best conditions and in the appropriate services. Moreover, the current diagnostic reference is reverse transcription by polymerase chain reaction (RT-PCR) on a nasopharyngeal sample taken by swab. This technique is expensive (54€) and its production time is several hours.
Alternative methods are in progress, including, rapid diagnostic tests. The MEMS microfluids and nanostructures (MMN) laboratory, in partnership with the Institut Chimie Biologie Innovation (CBI) (Paris, 75005), have developed a portable test "COVIDISC", low-cost (10 €), fast (1 hour), including extraction, elution and amplification in solid medium isothermal, reverse amplification loop mediated transcription (RT-LAMP).
The "lab" version has received an analytical validation on human nasopharyngeal samples with performance comparable to classic RT-PCR (sensitivity of 7 copies per μl, specificity 100%).
The objective of this study is to validate the in vitro diagnostic medical device, COVIDISC, with the standard nasopharyngeal RT-PCR test.
Detailed Description
All outpatients and hospitalized patients (intensive care unit, internal medicine service and emergency service) will be proposed to participate to the study after assessment of eligibility criteria by the investigator. The investigator will collect a written consent of the patient or from the support person or a familiar if, the patient is not in condition to consent. Patient's participation will be notified in his medical record.
After inclusion of patient, the nurse will collect general and clinical data and 2 nasopharyngeal swabs will be taken. One sample to test the prototype of the RT-LAMP and the second one to carry out the classic RT-PCR. The results will be collected and compared in a second step.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nasopharyngeal swabs
Arm Type
Experimental
Arm Description
One patient will have 2 nasopharyngeal for PCR and COVIDISC
Intervention Type
Diagnostic Test
Intervention Name(s)
Rapid Diagnostic Test vs PCR
Intervention Description
2 nasopharyngeal swabs taken for PCR and COVIDISC
Primary Outcome Measure Information:
Title
Comparaison of the performance of the diagnostic performance (sensitivity, sensibility) of RT-LAMP test using the RT-PCR test as a reference.
Description
Calculate sensitivity, Specificity, Positive predictive value, Negative predictive value, Positive and negative likelihood report COVIDISC fast, antigenic test compared to RT-PCR Covid-19 reference test conducted in the laboratory
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Compare the diagnostic performances of RT-LAMP to clinical diagnosis.
Description
The result of RT-LAMP test versus clinical evaluation defined by the clinical symptoms of the patients at the time of nasopharyngeal swab.
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients undergoing nasopharyngeal SARS CoV2 RT-PCR testing
Exclusion Criteria:
< 18 years old
Having signed a written informed consent form,
Affiliation to the social security system.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ROSSI Benjamin, MD
Organizational Affiliation
Hopital Robert Ballanger
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
NGUYEN Lee, MD
Organizational Affiliation
CMC Ambroise Paré
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHI Robert Ballanger
City
Aulnay-sous-Bois
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COVIDISC: Rapid Diagnostic Tests on Nasopharyngeal Swabs for the Detection of COVID-19
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